Total Knee ArthroplastyNCT06968143
Investigating Patient Satisfaction With Smart Knee Implants
A study testing Smart Knee Implant in people with Total Knee Arthroplasty and Knee Replacement, run by University of Chicago at 1 site in United States.
Trial summary
The main goal of this study is to see if there is a connection between the social and economic resources available in a patient's neighborhood (measured by the Area Deprivation Index, ADI) and their recovery after knee replacement surgery, as tracked through remote monitoring. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty, Knee Replacement, Knee Replacement Arthroplasty
- What is being tested?
- Smart Knee Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Patients undergoing unilateral primary or revision total knee arthroplasty with the smart knee implant or standard-of-care
Who cannot join
- Patients who receive contralateral knee replacement or contralateral or unilateral hip replacement within 90 days before or after their knee replacement in this study
- Patients with post-operative weight-bearing restrictions or physical deconditioning prohibiting routine physical therapy participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vincent Buckman, BS contact
United States1 site, 1 recruiting
- Recruiting
The University of Chicago Medical Center
Chicago, Illinois, 60637
Sara Wallace, MD, 773-834-3531, swallace2@bsd.uchicago.edu
About this study
Official title: Evaluating the Impact of Remote Therapeutic Monitoring on Knee Arthroplasty Recovery
The main goal of this study is to see if there is a connection between the social and economic resources available in a patient's neighborhood (measured by the Area Deprivation Index, ADI) and their recovery after knee replacement surgery, as tracked through remote monitoring. A secondary goal is to find out if patients' self-reported pain and function score are linked to their actual physical improvement after surgery as measured by a remote therapeutic monitoring (RTM) device. Additionally, this study examines whether RTM can reduce the number of postoperative clinic visits within the first 90 days after surgery while maintaining patient satisfaction and patient-reported outcome measures (PROMs).
Read the detailed description
Predicting and measuring knee function after total knee arthroplasty (TKA) has been a topic of debate in the field of orthopedic surgery for decades. The early recovery period after TKA is a critical time for achieving functional range of motion and mobility. For this reason, patients are traditionally examined at regular intervals during the postoperative period for evaluation. For patients who are not meeting targets during early recovery, interventions such as manipulation under anesthesia (MUA) or modifications to physical therapy protocols can improve outcomes. Remote therapeutic monitoring (RTM) using smart knee implants has been proposed as a means of enhancing postoperative follow-up with increased convenience to patients and without overburdening ambulatory resources. These smart knee implants collect objective recovery data including range-of-motion (ROM), step count, and cadence, and send these metrics to a mobile application so that patients and their practitioners can track their progress outside of the medical space. This study aims to compare post-operative patient-reported outcomes and satisfaction at multiple timepoints between patients with RTM and those with the current standard-of-care.
Insight into patient's functional recovery in their post-operative home environment may help orthopedic surgeons to better understand the impact of the social determinants of health (SDOH) on recovery. One of the methods of quantifying SDOH that has been popular in the healthcare field is the Area Deprivation Index (ADI). ADI was developed by the University of Wisconsin-Madison and uses patient addresses to display percentile-based information about neighborhood resources (including income, education, employment, and housing quality), quantifying healthcare accessibility. Some studies have found that while higher ADI may predict medical complications, non-home discharge, length of stay, and 90-day emergency department visits, there is low to no evidence that the metric is correlated with postoperative readmission rates, reoperation rates, or range of motion (ROM).Therefore, investigation into ADI as a predictor of outcomes following TKA needs to be further studied, particularly in juxtaposition with objective metrics of recovery.
The primary objective of this study is therefore to delineate if there is a correlation between the SDOH resources available to patients based on their home environment as measured by ADI, and remotely monitored functional outcomes after TKA . The secondary objective is to determine if patient-reported pain and function scores as measured by Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) correlate with remotely monitored functional improvement after TKA. The tertiary objective is to determine how patient satisfaction with surgery and postoperative recovery compares between patients with RTM and patients with standard knee replacements.
- Conditions
- Total Knee Arthroplasty, Knee Replacement, Knee Replacement Arthroplasty, Knee Osteoarthritis
- Being tested
- Smart Knee Implant
- Keywords
- Smart Knee Implant, Total Knee Arthroplasty, Remote Therapeutic Monitoring, Persona IQ
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Knee ImplantDevice
Also called Persona IQ
An important advancement in objective recovery data occurred when the first ever 'smart' knee implant for remote therapeutic monitoring (RTM) after total knee arthroplasty (TKA) was released in 2021. The implant includes both a prosthesis for TKA and a stem, the latter of which records the following metrics: step count, distance traveled, tibial range-of-motion (ROM), functional ROM, average walking speed, stride length, and cadence. The implant sends the recordings to a mobile platform. Additionally, it collects and analyzes patient across the entire population of users and creates percentiles for each metric based on patient age, gender and time since surgery. These "recovery curves" provide more objective data for practitioners and patients to evaluate recovery progress and make adjustments to their care plans accordingly.
| Study group | Role | What they receive |
|---|---|---|
| Smart Knee Implant | Experimental | This group will receive the smart knee implant during their arthroplasty and will be able to track their progress according to the smart metrics through a mobile application, and will otherwise have the same standard-of-care as the other arm. Receives: Device: Smart Knee Implant |
| Standard-of-Care Knee Arthroplasty | No intervention | This arm includes patients who are receiving the standard-of-care knee arthroplasty and will have standard follow-up with their surgeons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes and Satisfaction
The patients in both arms will complete surveys on their subjective pain and function as well as their subjective satisfaction with the knee arthroplasty preparation, surgery, and recovery. The investigators will compare these surveys between the experimental group and the standard-of-care group at select time points.
Measured: From enrollment to 1 year after arthroplasty
Secondary outcomes (3)
Area Deprivation Index Correlation with Recovery
The investigators will be retrospectively collecting patient records that will include patient neighborhood locations to calculate an Area Deprivation Index (ADI) score. These patients will be those who have received the smart knee implant before this study was approved, and the investigators will evaluate the correlation between smart knee implant recovery curve percentiles and the Area Deprivation Index in patients receiving the smart knee implant. A high Area Deprivation Index means being more socioeconomically deprived, and the scale is scored from 0 to 100.
Measured: up to 1 year
Correlation between Knee Injury and Osteoarthritis Outcome score for Joint Replacement (KOOS, JR.) and smart knee implant recovery curve percentiles
The investigators will collect the Knee Injury and Osteoarthritis Outcome score for Joint Replacement (KOOS, JR.) and smart knee implant recovery curve percentiles for the patients that receive smart knee implants and will calculate correlation scores between them. The KOOS, JR. is scored from 0 to 100 and a higher score means better knee function.
Measured: From enrollment to 1 year after arthroplasty
Complications after Knee Arthroplasty
The investigators will record the rate of patients requiring assistive walking devices, revision arthroplasty, manipulation under anesthesia, and the rates of periprosthetic joint infection between patients who receive smart knee implants and the standard-of-care joint arthroplasty.
Measured: From enrollment to 1 year after arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Sep 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be receiving, by their choice, either the smart knee implant, or the standard-of-care total knee arthroplasty. The two groups will have the same pre- and post-operative follow-up, except the smart knee implant group will be able to track their progress through a mobile application and see how they compare in their metrics against others of the same age and gender. Patients in both groups will complete the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) at their pre-operative, 6-week post-operative, 90-day post-operative, and 1-year post-operative appointments, and will also complete satisfaction surveys at their 6-week post-operative, 90-day post-operative, and 1-year post-operative appointments. The investigators will compare KOOS, JR. scores between the two groups and the investigators will also compare satisfaction scores between the smart knee implant and standard-of-care groups.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Wallace, MD, Principal investigator, The University of Chicago Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968143
- Sponsor's protocol ID
- IRB25-0508
- Status last verified
- Dec 2025
- First submitted
- 30 Apr 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Yocum D, Housholder E, Yergler J. Manipulation under Anesthesia Following TKA with Persona IQ: A Case Series. J Orthop Case Rep. 2023 Aug;13(8):127-131. doi: 10.13107/jocr.2023.v13.i08.3844.
PubMed 37654748Yocum D, Elashoff B, Verta P, Armock G, Yergler J. Patient reported outcomes do not correlate to functional knee recovery and range of motion in total knee arthroplasty. J Orthop. 2023 Jul 27;43:36-40. doi: 10.1016/j.jor.2023.07.009. eCollection 2023 Sep.
PubMed 37564705Shimizu MR, Buddhiraju A, Lin-Wei Chen T, Huang Z, Chen SF, Xiao P, RezazadehSaatlou M, Kwon YM. Socioeconomic area deprivation index is not associated with postoperative complications following revision total hip and knee joint arthroplasty. J Orthop. 2024 Jul 17;58:135-139. doi: 10.1016/j.jor.2024.07.008. eCollection 2024 Dec.
PubMed 39100544Calkins FM, Pagani NR, Bragg J, Gauthier Z, Salzler M. Neighborhood socioeconomic disadvantage does not predict need for manipulation under anesthesia or range of motion following total knee arthroplasty. J Orthop. 2024 Jun 15;58:146-149. doi: 10.1016/j.jor.2024.06.013. eCollection 2024 Dec.
PubMed 39100542Jevnikar BE, Huffman N, Roth A, Klika AK, Deren ME, Zhang C, Piuzzi NS; CCARR Corporate Authorship. Impacts of neighborhood deprivation on septic and aseptic revision total knee arthroplasty outcomes: A comprehensive analysis using the area deprivation index. Knee. 2024 Dec;51:74-83. doi: 10.1016/j.knee.2024.08.006. Epub 2024 Sep 5.
PubMed 39241673Shimizu MR, Buddhiraju A, Kwon OJ, Kerluku J, Huang Z, Kwon YM. The Utility of Neighborhood Social Vulnerability Indices in Predicting Non-Home Discharge Disposition Following Revision Total Joint Arthroplasty: A Comparison Study. J Arthroplasty. 2025 May;40(5):1148-1153. doi: 10.1016/j.arth.2024.10.118. Epub 2024 Oct 25.
PubMed 39490785Gordon AM, Ng MK, Elali F, Piuzzi NS, Mont MA. A Nationwide Analysis of the Impact of Socioeconomic Status on Complications and Health Care Utilizations After Total Knee Arthroplasty Using the Area Deprivation Index: Consideration of the Disadvantaged Patient. J Arthroplasty. 2024 Sep;39(9):2166-2172. doi: 10.1016/j.arth.2024.04.028. Epub 2024 Apr 12.
PubMed 38615971Zimmer Biomet and Canary Medical Announce FDA De Novo Classification Grant and Authorization to Market the World's First and Only Smart Knee Implant n.d. http://investor.zimmerbiomet.com/news-and-events/news/2021/08-30-2021-120155075 (accessed December 12, 2024).
Hsu H, Siwiec RM. Knee Arthroplasty. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507914/
PubMed 29939691Bourne RB. Measuring tools for functional outcomes in total knee arthroplasty. Clin Orthop Relat Res. 2008 Nov;466(11):2634-8. doi: 10.1007/s11999-008-0468-0. Epub 2008 Sep 9.
PubMed 18780136Yoshida Y, Zeni J, Snyder-Mackler L. Do patients achieve normal gait patterns 3 years after total knee arthroplasty? J Orthop Sports Phys Ther. 2012 Dec;42(12):1039-49. doi: 10.2519/jospt.2012.3763. Epub 2012 Oct 22.
PubMed 23090437
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Remote Therapeutic Monitoring on Knee Arthroplasty Recovery
- ClinicalTrials.gov ID
- NCT06968143
- Acronym / sponsor ID
- IRB25-0508
- Conditions
- Total Knee Arthroplasty, Knee Replacement, Knee Replacement Arthroplasty, Knee Osteoarthritis
- Keywords
- Smart Knee Implant, Total Knee Arthroplasty, Remote Therapeutic Monitoring, Persona IQ
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to see if there is a connection between the social and economic resources available in a patient's neighborhood (measured by the Area Deprivation Index, ADI) and their recovery after knee replacement surgery, as tracked through remote monitoring. A secondary goal is to find out if patients' self-reported pain and function score are linked to their actual physical improvement after surgery as measured by a remote therapeutic monitoring (RTM) device. Additionally, this study examines whether RTM can reduce the number of postoperative clinic visits within the first 90 days after surgery while maintaining patient satisfaction and patient-reported outcome measures (PROMs).
Detailed description
Predicting and measuring knee function after total knee arthroplasty (TKA) has been a topic of debate in the field of orthopedic surgery for decades. The early recovery period after TKA is a critical time for achieving functional range of motion and mobility. For this reason, patients are traditionally examined at regular intervals during the postoperative period for evaluation. For patients who are not meeting targets during early recovery, interventions such as manipulation under anesthesia (MUA) or modifications to physical therapy protocols can improve outcomes. Remote therapeutic monitoring (RTM) using smart knee implants has been proposed as a means of enhancing postoperative follow-up with increased convenience to patients and without overburdening ambulatory resources. These smart knee implants collect objective recovery data including range-of-motion (ROM), step count, and cadence, and send these metrics to a mobile application so that patients and their practitioners can track their progress outside of the medical space. This study aims to compare post-operative patient-reported outcomes and satisfaction at multiple timepoints between patients with RTM and those with the current standard-of-care.
Insight into patient's functional recovery in their post-operative home environment may help orthopedic surgeons to better understand the impact of the social determinants of health (SDOH) on recovery. One of the methods of quantifying SDOH that has been popular in the healthcare field is the Area Deprivation Index (ADI). ADI was developed by the University of Wisconsin-Madison and uses patient addresses to display percentile-based information about neighborhood resources (including income, education, employment, and housing quality), quantifying healthcare accessibility. Some studies have found that while higher ADI may predict medical complications, non-home discharge, length of stay, and 90-day emergency department visits, there is low to no evidence that the metric is correlated with postoperative readmission rates, reoperation rates, or range of motion (ROM).Therefore, investigation into ADI as a predictor of outcomes following TKA needs to be further studied, particularly in juxtaposition with objective metrics of recovery.
The primary objective of this study is therefore to delineate if there is a correlation between the SDOH resources available to patients based on their home environment as measured by ADI, and remotely monitored functional outcomes after TKA . The secondary objective is to determine if patient-reported pain and function scores as measured by Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) correlate with remotely monitored functional improvement after TKA. The tertiary objective is to determine how patient satisfaction with surgery and postoperative recovery compares between patients with RTM and patients with standard knee replacements.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will be receiving, by their choice, either the smart knee implant, or the standard-of-care total knee arthroplasty. The two groups will have the same pre- and post-operative follow-up, except the smart knee implant group will be able to track their progress through a mobile application and see how they compare in their metrics against others of the same age and gender. Patients in both groups will complete the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) at their pre-operative, 6-week post-operative, 90-day post-operative, and 1-year post-operative appointments, and will also complete satisfaction surveys at their 6-week post-operative, 90-day post-operative, and 1-year post-operative appointments. The investigators will compare KOOS, JR. scores between the two groups and the investigators will also compare satisfaction scores between the smart knee implant and standard-of-care groups.
| Arm | Type | Receives |
|---|---|---|
| Smart Knee Implant | Experimental | Device: Smart Knee ImplantThis group will receive the smart knee implant during their arthroplasty and will be able to track their progress according to the smart metrics through a mobile application, and will otherwise have the same standard-of-care as the other arm. |
| Standard-of-Care Knee Arthroplasty | No intervention | –This arm includes patients who are receiving the standard-of-care knee arthroplasty and will have standard follow-up with their surgeons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Patients undergoing unilateral primary or revision total knee arthroplasty with the smart knee implant or standard-of-care
Key exclusion criteria (2 listed)
- Patients who receive contralateral knee replacement or contralateral or unilateral hip replacement within 90 days before or after their knee replacement in this study
- Patients with post-operative weight-bearing restrictions or physical deconditioning prohibiting routine physical therapy participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Knee ImplantAlso: Persona IQAn important advancement in objective recovery data occurred when the first ever 'smart' knee implant for remote therapeutic monitoring (RTM) after total knee arthroplasty (TKA) was released in 2021. The implant includes both a prosthesis for TKA and a stem, the latter of which records the following metrics: step count, distance traveled, tibial range-of-motion (ROM), functional ROM, average walking speed, stride length, and cadence. The implant sends the recordings to a mobile platform. Additionally, it collects and analyzes patient across the entire population of users and creates percentiles for each metric based on patient age, gender and time since surgery. These "recovery curves" provide more objective data for practitioners and patients to evaluate recovery progress and make adjustments to their care plans accordingly. | Device | Smart Knee Implant |
Primary outcome
Patient-Reported Outcomes and Satisfaction
Time frame: From enrollment to 1 year after arthroplasty
The patients in both arms will complete surveys on their subjective pain and function as well as their subjective satisfaction with the knee arthroplasty preparation, surgery, and recovery. The investigators will compare these surveys between the experimental group and the standard-of-care group at select time points.
3 secondary outcomes
Area Deprivation Index Correlation with Recovery
Time frame: up to 1 year
Correlation between Knee Injury and Osteoarthritis Outcome score for Joint Replacement (KOOS, JR.) and smart knee implant recovery curve percentiles
Time frame: From enrollment to 1 year after arthroplasty
Complications after Knee Arthroplasty
Time frame: From enrollment to 1 year after arthroplasty
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 37654748Yocum D, Housholder E, Yergler J. Manipulation under Anesthesia Following TKA with Persona IQ: A Case Series. J Orthop Case Rep. 2023 Aug;13(8):127-131. doi: 10.13107/jocr.2023.v13.i08.3844.
- Background: PubMed 37564705Yocum D, Elashoff B, Verta P, Armock G, Yergler J. Patient reported outcomes do not correlate to functional knee recovery and range of motion in total knee arthroplasty. J Orthop. 2023 Jul 27;43:36-40. doi: 10.1016/j.jor.2023.07.009. eCollection 2023 Sep.
- Background: PubMed 39100544Shimizu MR, Buddhiraju A, Lin-Wei Chen T, Huang Z, Chen SF, Xiao P, RezazadehSaatlou M, Kwon YM. Socioeconomic area deprivation index is not associated with postoperative complications following revision total hip and knee joint arthroplasty. J Orthop. 2024 Jul 17;58:135-139. doi: 10.1016/j.jor.2024.07.008. eCollection 2024 Dec.
- Background: PubMed 39100542Calkins FM, Pagani NR, Bragg J, Gauthier Z, Salzler M. Neighborhood socioeconomic disadvantage does not predict need for manipulation under anesthesia or range of motion following total knee arthroplasty. J Orthop. 2024 Jun 15;58:146-149. doi: 10.1016/j.jor.2024.06.013. eCollection 2024 Dec.
- Background: PubMed 39241673Jevnikar BE, Huffman N, Roth A, Klika AK, Deren ME, Zhang C, Piuzzi NS; CCARR Corporate Authorship. Impacts of neighborhood deprivation on septic and aseptic revision total knee arthroplasty outcomes: A comprehensive analysis using the area deprivation index. Knee. 2024 Dec;51:74-83. doi: 10.1016/j.knee.2024.08.006. Epub 2024 Sep 5.
- Background: PubMed 39490785Shimizu MR, Buddhiraju A, Kwon OJ, Kerluku J, Huang Z, Kwon YM. The Utility of Neighborhood Social Vulnerability Indices in Predicting Non-Home Discharge Disposition Following Revision Total Joint Arthroplasty: A Comparison Study. J Arthroplasty. 2025 May;40(5):1148-1153. doi: 10.1016/j.arth.2024.10.118. Epub 2024 Oct 25.
- Background: PubMed 38615971Gordon AM, Ng MK, Elali F, Piuzzi NS, Mont MA. A Nationwide Analysis of the Impact of Socioeconomic Status on Complications and Health Care Utilizations After Total Knee Arthroplasty Using the Area Deprivation Index: Consideration of the Disadvantaged Patient. J Arthroplasty. 2024 Sep;39(9):2166-2172. doi: 10.1016/j.arth.2024.04.028. Epub 2024 Apr 12.
- BackgroundZimmer Biomet and Canary Medical Announce FDA De Novo Classification Grant and Authorization to Market the World's First and Only Smart Knee Implant n.d. http://investor.zimmerbiomet.com/news-and-events/news/2021/08-30-2021-120155075 (accessed December 12, 2024).
- Background: PubMed 29939691Hsu H, Siwiec RM. Knee Arthroplasty. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507914/
- Background: PubMed 18780136Bourne RB. Measuring tools for functional outcomes in total knee arthroplasty. Clin Orthop Relat Res. 2008 Nov;466(11):2634-8. doi: 10.1007/s11999-008-0468-0. Epub 2008 Sep 9.
- Background: PubMed 23090437Yoshida Y, Zeni J, Snyder-Mackler L. Do patients achieve normal gait patterns 3 years after total knee arthroplasty? J Orthop Sports Phys Ther. 2012 Dec;42(12):1039-49. doi: 10.2519/jospt.2012.3763. Epub 2012 Oct 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent Buckman, BS contact
Sara Wallace, MD principal investigator
The University of Chicago Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Knee Implant in people with Total Knee Arthroplasty and Knee Replacement, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malik J Scott, BA (773-834-0822, mjscott1@uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes and Satisfaction (time frame: From enrollment to 1 year after arthroplasty). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06968143, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.